FDA 510(k)

ACUVUE (senofilcon A) 다중 포커스 소프트 콘택트 렌즈

K-번호: K200243 · 2020-03-17

결정일2020-03-17

제품 코드LPL

자문 위원회의료장비 규제 텍스트 번역 OP

결정대체적으로 동일

기기 요약

ACUVUE (senofilcon A) Soft Contact Lens Multifocal is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Vision Care, Inc.. It received FDA 510(k) clearance on 2020-03-17 under 510(k) number K200243. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ACUVUE (senofilcon A) Soft Contact Lens Multifocal?

ACUVUE (senofilcon A) Soft Contact Lens Multifocal is a medical device that received FDA 510(k) clearance on 2020-03-17. The listed applicant is Johnson & Johnson Vision Care, Inc.. The 510(k) number is K200243.

When did ACUVUE (senofilcon A) Soft Contact Lens Multifocal receive FDA 510(k) clearance?

ACUVUE (senofilcon A) Soft Contact Lens Multifocal received FDA 510(k) clearance on 2020-03-17, under 510(k) number K200243.

Who is the listed applicant for ACUVUE (senofilcon A) Soft Contact Lens Multifocal?

The FDA 510(k) record lists Johnson & Johnson Vision Care, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUVUE (senofilcon A) Soft Contact Lens Multifocal?

The FDA product code for ACUVUE (senofilcon A) Soft Contact Lens Multifocal is LPL.

Johnson & Johnson Vision Care, Inc.를 신청인으로 등재한 기타 기록

K210930ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)K180299ACUVUE OASYS (senofilcon A) with Photochromic Additive K160212ACUVUE (senofilcon C) 소프트 콘택트 렌즈

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